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NCT00392171

The Effects of Continuous 28-day (28/28) Temozolomide Chemotherapy in Subjects With Recurrent Malignant Glioma Who Have Failed the Conventional 5-day (5/28) Treatment (P04601)

Completed Phase 2 Results posted Last updated 7 June 2017
What this trial tests

Phase 2 trial testing Temozolomide in Glioma in 120 participants. Completed in 15 September 2009.

Timeline
9 June 2006
Primary endpoint
15 September 2009
15 September 2009

Quick facts

Lead sponsorMerck Sharp & Dohme LLC
PhasePhase 2
StatusCompleted
Study typeINTERVENTIONAL
Allocationnon randomized
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment120
Start date9 June 2006
Primary completion15 September 2009
Estimated completion15 September 2009

Drugs / interventions tested

Conditions studied

Sponsor

Merck Sharp & Dohme LLC — full company profile →

Who can join

Adults 19 to 70, any sex, with Glioma or Astrocytoma. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Percentage of Participants Surviving at Six Months of Treatment Without Evidence of Disease Progression. Primary · 6 months

Progression-free survival as determined by Kaplan-Meier method.

Anaplastic Glioma (n=28)
GroupValue95% CI
Temozolomide35.7
Early Glioblastoma Multiforme (GBM) (n=33)
GroupValue95% CI
Temozolomide27.3
Extended Glioblastoma Multiforme (GBM) (n=27)
GroupValue95% CI
Temozolomide7.4
Rechallenge Glioblastoma Multiforme (GBM) (n=28)
GroupValue95% CI
Temozolomide35.7

Adverse events — posted to ClinicalTrials.gov

Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Temozolomide
Serious: 27/120 (23%)
Deaths:

Serious adverse events (38 terms)

ReactionSystemTemozolomide
CONVULSIONNervous system disorders
CONFUSIONAL STATEPsychiatric disorders
GENERAL PHYSICAL HEALTH DETERIORATIONGeneral disorders
PAINGeneral disorders
APHASIANervous system disorders
HEADACHENervous system disorders
LEUKOPENIABlood and lymphatic system disorders
NEUTROPENIABlood and lymphatic system disorders
THROMBOCYTOPENIABlood and lymphatic system disorders
MYOCARDIAL INFARCTIONCardiac disorders
NAUSEAGastrointestinal disorders
PANCREATITISGastrointestinal disorders
VOMITINGGastrointestinal disorders
ASTHENIAGeneral disorders
IRRITABILITYGeneral disorders
HERPES ZOSTERInfections and infestations
CONTUSIONInjury, poisoning and procedural complications
HEPATIC ENZYME INCREASEDInvestigations
HYPERGLYCAEMIAMetabolism and nutrition disorders
ARTHRALGIAMusculoskeletal and connective tissue disorders
NEOPLASM PROGRESSIONNeoplasms benign, malignant and unspecified (incl cysts and polyps)
TUMOUR HAEMORRHAGENeoplasms benign, malignant and unspecified (incl cysts and polyps)
ATAXIANervous system disorders
BALANCE DISORDERNervous system disorders
CEREBRAL HAEMORRHAGENervous system disorders
Other adverse events (30 terms — click to expand)

ReactionSystemTemozolomide
FATIGUEGeneral disorders
NAUSEAGastrointestinal disorders
HEADACHENervous system disorders
VOMITINGGastrointestinal disorders
HEMIPARESISNervous system disorders
MEMORY IMPAIRMENTNervous system disorders
CONVULSIONNervous system disorders
CONSTIPATIONGastrointestinal disorders
COUGHRespiratory, thoracic and mediastinal disorders
GAIT DISTURBANCEGeneral disorders
CONFUSIONAL STATEPsychiatric disorders
INSOMNIAPsychiatric disorders
MONOPARESISNervous system disorders
ORAL CANDIDIASISInfections and infestations
SOMNOLENCENervous system disorders
DYSPNOEARespiratory, thoracic and mediastinal disorders
RASHSkin and subcutaneous tissue disorders
OEDEMA PERIPHERALGeneral disorders
BALANCE DISORDERNervous system disorders
DIARRHOEAGastrointestinal disorders
ASTHENIAGeneral disorders
ARTHRALGIAMusculoskeletal and connective tissue disorders
DIZZINESSNervous system disorders
HEMIANOPIANervous system disorders
NEUTROPENIABlood and lymphatic system disorders
VISION BLURREDEye disorders
DYSPEPSIAGastrointestinal disorders
OEDEMAGeneral disorders
HYPOAESTHESIANervous system disorders
SPEECH DISORDERNervous system disorders

Most-reported serious reactions: CONVULSION, CONFUSIONAL STATE, GENERAL PHYSICAL HEALTH DETERIORATION, PAIN, APHASIA, HEADACHE, LEUKOPENIA, NEUTROPENIA.

Data from ClinicalTrials.gov NCT00392171 adverse events section.

Sponsor's own description

The purpose of this non-randomized, open-label, multicenter, Phase II, 2-stage design, RESCUE study is to test the hypothesis that continuous 28-day oral dosing (28/28) with dose-intense temozolomide (50 mg/m\^2) for up to 12 months may overcome resistance and be effective in the management of adult patients with malignant glioma who have failed following at least 2 cycles (2 months) of conventional 5-day (5/28) cycles of high-dose temozolomide (150-200 mg/m\^2).

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Translational gap in ongoing clinical trials for glioma.
    Guishard AF, Yakisich JS, Azad N, Iyer AKV. · · 2018 · cited 17× · PMID 29066236 · DOI 10.1016/j.jocn.2017.10.001
  2. Temozolomide and MGMT forever?
    Weller M. · · 2010 · cited 4× · PMID 20167809 · DOI 10.1093/neuonc/noq016

Verify or expand the search:

Other trials of Temozolomide

Trials testing the same drug.

Other recruiting trials for Glioma

Currently open trials in the same condition.

Other Merck Sharp & Dohme LLC trials

Trials by the same sponsor.

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Data sources for this page

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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing